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Closed-loop insulin delivery versus sensor-augmented pump therapy in older adults with type 1 diabetes (ORACL): a randomized, crossover trial

McAuley, Sybil A., Trawley, Steven, Vogrin, Sara, Ward, Glenn M., Fourlanos, Spiros, Grills, Charlotte A., Lee, Melissa H., Alipoor, Andisheh Mohammad +5 more·2022·Diabetes Care
DOI 10.2337/dc21-1667

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Abstract

Objective To assess the efficacy and safety of closed-loop insulin delivery compared with sensor-augmented pump therapy among older adults with type 1 diabetes. Research design and methods This open-label, randomized (1:1), crossover trial compared 4 months of closed-loop versus sensor-augmented pump therapy. Eligible adults were aged ≥60 years, with type 1 diabetes (duration ≥10 years), using an insulin pump. The primary outcome was continuous glucose monitoring (CGM) time in range (TIR; 3.9-10.0 mmol/L). Results There were 30 participants (mean age 67 [SD 5] years), with median type 1 diabetes duration of 38 years (interquartile range [IQR] 20-47), randomized (n = 15 to each sequence); all completed the trial. The mean TIR was 75.2% (SD 6.3) during the closed-loop stage and 69.0% (9.1) during the sensor-augmented pump stage (difference of 6.2 percentage points [95% CI 4.4 to 8.0]; P Conclusions Closed-loop therapy is an effective treatment option for older adults with long-duration type 1 diabetes, and no safety issues were identified. These older adults had higher TIR accompanied by less time below range during closed loop than during sensor-augmented pump therapy. Of particular clinical importance, closed loop reduced the time spent in hypoglycemic range overnight.

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Crossref · 10.2337/dc21-1667

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10 of 10 references verified0 citation errors · 0 not checkable

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  • The ORACL trial found small but significant decreases in hypoglycemia with the automated insulin delivery strategy.

    “Moreover, they found small but significant decreases in hypoglycemia with the AID strategy.”

    From 13. Older Adults: <i>Standards of Care in Diabetes—2024</i> (2024) · cites this paper as [44]

  • The ORACL trial in 30 older adults (mean age 67 years) with type 1 diabetes found that an automated insulin delivery strategy was associated with significant improvements in time in range compared with sensor-augmented pump therapy.

    “The Older Adult Closed Loop (ORACL) trial in 30 older adults (mean age 67 years) with type 1 diabetes found that an automated insulin delivery (AID) strategy was associated with significant improvements in time in range compared with sensoraugmented pump therapy (44).”

    From 13. Older Adults: <i>Standards of Care in Diabetes—2024</i> (2024) · cites this paper as [44]

  • The ORACL trial in 30 older adults (mean age 67 years) with type 1 diabetes found that an automated insulin delivery (AID) strategy was associated with significant improvements in time in range compared with sensor-augmented pump therapy.

    “The Older Adult Closed Loop (ORACL) trial in 30 older adults (mean age 67 years) with type 1 diabetes found that an automated insulin delivery (AID) strategy was associated with significant improvements in TIR compared with sensoraugmented pump therapy (47).”

    From 13. Older Adults: Standards of Care in Diabetes—2025 (2025) · cites this paper as [47]

  • The ORACL trial found small but significant decreases in hypoglycemia with the AID strategy.

    “Moreover, they found small but significant decreases in hypoglycemia with the AID strategy.”

    From 13. Older Adults: Standards of Care in Diabetes—2025 (2025) · cites this paper as [47]

  • In the ORACL trial in 30 older adults (mean age 67 years) with type 1 diabetes, an automated insulin delivery (AID) strategy was associated with significant improvements in time in range (TIR), as well as modest improvements in hypoglycemia, compared with sensor-augmented pump therapy.

    “The Older Adult Closed Loop (ORACL) trial in 30 older adults (mean age 67 years) with type 1 diabetes found that an automated insulin delivery (AID) strategy was associated with significant improvements in time in range (TIR), as well as modest improvements in hypoglycemia, compared with sensor-augmented pump therapy (52).”

    From 13. Older Adults: Standards of Care in Diabetes—2026 (2026) · cites this paper as [52]

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Authors
McAuley, S. A., Trawley, S., Vogrin, S., Ward, G. M., Fourlanos, S., Grills, C. A., Lee, M. H., Alipoor, A. M., O’Neal, D. N., O’Regan, N. A., Sundararajan, V., Colman, P. G., & MacIsaac, R. J.
Affiliations
  • The University of Melbourne (AU)
  • The Royal Melbourne Hospital (AU)
  • Department of Medicine, The University of Melbourne, Melbourne, Australia
  • University Hospital Waterford (IE)
ORCID
Venue
Diabetes Care
Publisher
American Diabetes Association
Published
2021-11-29
Volume
45
Issue
2
Pages
381-390
ISSN
0149-5992 (ISSN-L)
DOI
10.2337/dc21-1667
OpenAlex
W3215660496
Cited by
117
References
10
Citations by year
2026: 21 · 2025: 29 · 2024: 29 · 2023: 21 · 2022: 17
FWCI
12.49
Type
journal article
Language
en
Open access
closed
Licence
www.diabetesjournals.org/content/license (vor)
Locations
  • Diabetes Care (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
Keywords
artificial pancreas, sensor-augmented pump therapy, type 1 diabetes, older adults, continuous glucose monitoring, time in range, glycemic control, hypoglycemia, diabetic ketoacidosis, insulin pump, HbA1c, comparative efficacy and safety, crossover design
MeSH terms
Aged, Blood Glucose, Diabetes Mellitus, Type 1, Humans, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Middle Aged, Blood Glucose Self-Monitoring, Cross-Over Studies

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